Happy, dancing patients and weaponizing disclosures

I’m not a fan of prescription drug advertising. I’d happily watch Jeopardy! without all the happy, dancing patients that parade across the screen between rounds of that popular game show. And as FDA Commissioner Dr. Marty Makary argued in the New York Times last week, those ads can be misleading. Require more accuracy and fewer septugenarians doing the TV commercial tango? Fine with me.

Makary says FDA’s push is focused on reigning in branded manufacturer advertising practices, including the use of social media influencers. This isn’t about telehealth or compounders per se – it’s part of a broader effort rooted in frustration with the advertising behavior of traditional pharma and the agency's failure to monitor or enforce their behavior over the last decade.

(Respectfully, I think Dr. Makary is wrong about the telehealth ad he criticizes. He says it fails to disclose side effects. But the ad never mentions a drug or even a class of drugs. It mentions a condition, much like the corporate ads drugmakers run about their work on cancer cures. Pfizer, for instance, doesn’t have to disclose side effects in those kinds of spots, nor should it.)

But I’m troubled that misunderstandings may rope compounded drugs into this effort and ultimately require for them disclosures that can’t reasonably be made about the drugs. APC members are committed to providing patients clear and accurate information to make the best decisions about their health. But attaching side effects disclosures to compounded drugs – without research clinical trials to validate those possible side effects – could impose a standard that can’t be met. And that could well keep patients from getting the therapies their prescribers judge they need – drugs for which there’s no suitable FDA corollary.

At the same time, there are disclosures we support. For instance, we support a requirement in law that the following disclosure be added to the labeling of compounded drugs: “This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.” In fact, it’s a part of legislation introduced last week by Reps. Diana Harshbarger (TN) and Buddy Carter (GA) – HR 5316.

If the goal of this new FDA campaign is to protect patients, let’s be careful not to weaponize “disclosure” in ways that actually harm them. For compounded drugs, requiring disclosures where none can credibly be made would create a standard designed to fail — and in failing, it would deprive patients of access to therapies their prescribers have judged essential. That’s not consumer protection; that’s regulatory overreach. A better path is transparency that is truthful and feasible, like the simple statement now before Congress acknowledging that compounded drugs are not FDA-approved. That kind of disclosure empowers patients without eliminating their options.

Scott Brunner is chief executive officer with the Alliance for Pharmacy Compounding.